Job Description
ORGENTEC Diagnostika GmbH is the global market leader in the development and production of test systems for the diagnosis of infectious and autoimmune diseases. As part of the Sebia Group, headquartered in Lisses, France, ORGENTEC supplies medical laboratories in over 100 countries with highly specialised and innovative devices and test kits. Our company is characterised by steady and sustainable growth in an internationally oriented, future-oriented business field.
To strengthen our team at the Mainz site, we are looking for a
Clinical Affairs Associate (m/f/d)
- Support preparation, maintenance, and management of design documentation of legacy IVD products.
- Support the creation of IVDR-compliant clinical evidence documentation, including study plans and reports for regulatory submissions (PEP / PER, CPR, SVR, SOTA).
- Contribute to coordination and implementation of clinical studies that support regulatory submissions, including pre-market approvals (PMA), 510(k) notification, and CE marking.
- Contribute to post-market performance follow-up studies and surveys to ensure ongoing compliance throughout the product lifecycle.
- Perform systematic literature research to support scientific validity and state-of-the-art and post- market surveillance.
- Ensure compliance with all regulatory standards across different regions, including FDA, EMA, and other international regulatory agencies.
- Ensure compliance with legal and regulatory requirements across different jurisdictions, including adherence to good clinical practice (GCP), ISO standards, and relevant in vitro diagnostic device regulations (IVDD / IVDR).
- Master's degree or higher in a relevant life science discipline, e.g., biology, biochemistry, chemistry; a PhD is preferred
- Minimum of 3 years of working experience in R&D, preferably in the IVD industry or medical device industry, a strong background in autoimmunity and infectious diseases would be beneficial
- Careful, accurate and responsible way of working, good documentation practice
- Experience in technical, scientific or medical writing and document management
- Strong analytical and problem-solving abilities
- Understanding of standard landscape (ISO, CLSI, 21CFR)
- Confident in the use of MS Office and statistical software, knowledge of document management systems would be a plus
- Proficient in German and English
- Permanent employment contract
- A crisis-proof job with an attractive income
- Annual salary review
- Flexible working hours
- Individualised employee development and training
- Attractive package of health and social benefits (e.g., subsidised computer glasses, flu vaccination, employer contribution of 30% to private pension scheme)
- Employer subsidy for the canteen, free drinks
- Crèche and kindergarten allowance (max. 200€)
- Employee discounts with well-known brands
- Anniversary bonus
- Car park directly on site